(55 days)
No
The device description and performance studies focus solely on the mechanical properties and equivalence to predicate devices, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is described as an "internal fixation" system for "arthrodeses, osteotomies, fractures and nonunions," which directly treats medical conditions related to the musculoskeletal system.
No
This device is an internal fixation system for bones, not a device used to diagnose medical conditions or diseases. Its purpose is to physically stabilize fractures and nonunions.
No
The device description explicitly states it consists of physical components: titanium plates, titanium alloy screws, and instruments. It is a hardware-based bone fixation system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle". This describes a surgical implant used to stabilize bones within the body.
- Device Description: The device is described as a "bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws". This further confirms it's a physical implant for surgical use.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
The Omni Foot Plating System is internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Omni Foot Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot & ankle including the fore-, mid-, and hind foot and ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: The new geometries of the Omni Foot plates were compared to the Arix Foot System plates (K161864 and K170780) by engineering analysis. The results of this analysis indicate that the Omni Foot Plating System is equivalent to predicate device.
Clinical Testing: No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K172260, K170780, K161864, K143188
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized human figure. To the right of that is the logo for the U.S. Food & Drug Administration (FDA), with the letters FDA in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
May 22, 2018
Extremity Medical, LLC Brian Smekal VP, Regulatory Affairs and Quality Assurance 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
Re: K180808
Trade/Device Name: Omni Foot Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: March 27, 2018 Received: March 28, 2018
Dear Brian Smekal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Omni Foot Plating System
Indications for Use (Describe)
The Omni Foot Plaing System is internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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K180808 Page 1 of 2
510(k) Summary
Omni Foot Plating System
| Submitter | Extremity Medical, LLC.
300 Interpace Parkway, Suite 410
Parsippany, NJ 07054 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brian Smekal, MS, RAC
VP, Regulatory Affairs and Quality Assurance
Phone: (973) 588-8988
Email: bsmekal@extremitymedical.com |
| Date Prepared | May 10, 2018 |
| Trade Name | Omni Foot Plating System |
| Common Name | Bone plates and screws |
| Classification
Name and
Number | 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and
accessories; 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Product Code | HRS, HWC |
| Predicate
Devices | K172260 - Omni Foot Plating System
K170780 - Arix Foot System (2.3/2.8)
K161864 – Arix Foot System
K143188 - 3.0mm Biomet Cannulated Screw System |
| Device
Description | The Omni Foot Plating System is a bone fixation system consisting of unalloyed Titanium
plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet
ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and
delivery. The plates are available in various configurations, essentially differing by the
lengths and number of holes. The plate screws are provided in diameters of 2.8mm and
3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws in
various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be
used with a specialized locking screw ("Post") which contains a locking feature at the distal
end for compression/stabilization. |
| Indications for
use | The Omni Foot Plating System is intended for use in internal fixation of arthrodeses,
osteotomies, fractures and nonunions of the small bones of the foot & ankle including the
fore-, mid-, and hind foot and ankle applications. |
| Statement of
Technological
Comparison | Omni Foot System, Bone Plates: Based on a technical feature comparison, the subject
device was found to be similar to all predicate devices with regard to design and materials.
The subject plates also have a polyaxial locking feature, identical to the design used in the
predicate device (K161864 and K170780).
Omni Foot System, Bone Screws: They are identical in design of the screws previously
cleared under K172260 – Omni Foot Plating System. |
| Non-clinical
Testing | The new geometries of the Omni Foot plates were compared to the Arix Foot System plates
(K161864 and K170780) by engineering analysis. The results of this analysis indicate that
the Omni Foot Plating System is equivalent to predicate device. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The Omni Foot Plating System is substantially equivalent to its predicate devices. This
conclusion is based upon indications for use, principles of operation, design, and
engineering analysis. |
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